DLP-114 is a long-acting formulation of the antipsychotic risperidone for schizophrenia maintenance therapy. The open-label study is to evaluate the safety, tolerability and pharmacokinetics of switching from oral risperidone to the once- or twice-yearly DLP-114 risperidone implant, according to a news release.
Brisbane, Calif.-base Delpor already completed a Phase 1 trial in healthy subjects to test the safety, tolerability and pharmacokinetics of DLP-114. The second trial will evaluate the switch from 2 mg/day or 3 mg/day oral risperidone to two implants over a six- or 12-month dosing period. The trial is in collaboration with the National Institute of Mental Health.
Delpor’s Prozor technology is designed to enable the sustained release of drugs from a non-mechanical, matchstick-long, implantable drug delivery device implanted in the abdomen during a 10-minute in-office procedure. The implant can be easily removed within minutes if required, too.
The implant is designed to deliver therapeutic levels of the drug for as long as one year, with potential benefits including reduced relapses due to medication adherence and a steady drug release that reduces adverse events like peaks or sub-therapeutic troughs.
“The dosing of the first patient in our Phase 1b/2a clinical trial is an important milestone for Delpor and our lead asset, DLP-114,” Delpor president & CEO Tassos Nicolaou said in the release. “Medication adherence is a significant challenge for patients with chronic conditions. Using Delpor’s proprietary Prozor technology, we’ve created DLP-114, a once-yearly, or twice-yearly risperidone implant that has the potential to significantly advance treatment outcomes for individuals with schizophrenia by improving medication adherence, and delivering a “smooth” pharmacokinetic profile resulting in enhanced safety and tolerability.”
